Breast biopsy lateral arm system

ABSTRACT

A biopsy device includes a lateral member; a gun mount configured to support a biopsy gun, the gun mount being connected to the lateral member and movable along a first axis with respect to the lateral member, and a sensor which detects a position of the gun mount along the first axis with respect to the lateral member and generates positional data which is provided to an interface module. The gun mount can also be reconfigured in orientations which are offset in a dimension which is orthogonal to the first axis, orientations rotationally offset about the first axis or an axis parallel to the first axis. The lateral member can be in right hand and left hand orientations. Various sensors detect these reconfigurations and provide corresponding data to the interface module for additional calculations and display.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/095,394, inventors John Girgenti et al., filed Apr. 11,2016, which, in turn, is a continuation of U.S. patent application Ser.No. 13/611,502, inventors John Girgenti et al., filed Sep. 12, 2012, nowU.S. Pat. No. 9,308,017, which, in turn, claims priority under 35 U.S.C.119(e) to U.S. Provisional Patent Application No. 61/535,401 titledBreast Biopsy Lateral Arm System, inventors John Girgenti et al., filedSep. 16, 2011, the disclosures of all of which are incorporated hereinby reference in their entireties.

BACKGROUND

The subject matter of this disclosure is generally related to themedical field. Medical imaging technologies such as stereotactic x-ray,fluoroscopy, computer tomography, ultrasound, nuclear medicine andmagnetic resonance imaging enable detection of small abnormalities inthe body of a patient. The discovery of certain abnormalities may promptperformance of a biopsy procedure to a tissue sample for lab analysis tohelp diagnose and treat patients suspected of having cancerous tumors,pre-malignant conditions or other diseases or disorders. A stereotacticguided percutaneous breast biopsy is often preferable to an opensurgical breast biopsy in the case of small abnormalities located deepwithin the body because a percutaneous biopsy removes a relatively smallamount of tissue. For example, a needle can be used to remove individualcells or clusters of cells in the case of fine needle aspiration (FNA),and a core or fragment of tissue in the case of a core biopsy. Onedifficulty associated with such procedures is that it is necessary tolocate the biopsy needle with considerable precision in order to obtaina suitable sample of a small abnormality, particularly if it is locateddeep within the body. Biopsy guns and guidance systems have beendeveloped to facilitate accurate location of a biopsy needle. However,while these devices offer some advantages, manual computations may berequired for configuration. Further, systems may only be suitable foruse with certain patients due to size and reconfiguration limitations.

SUMMARY

In accordance with an aspect an apparatus comprises: a lateral member; agun mount configured to support a biopsy gun, the gun mount beingconnected to the lateral member and movable along a first axis withrespect to the lateral member; and a sensor which detects a position ofthe gun mount along the first axis with respect to the lateral memberand generates positional data which is provided to an interface module.

In accordance with another aspect a method comprises: mounting a biopsygun in a gun mount connected to a lateral member; moving the biopsy gunalong a first axis with respect to the lateral member; and detecting aposition of the gun mount along the first axis with respect to thelateral member with a sensor; and generating positional data which isprovided to an interface module and presented to an operator.

In addition to allowing reconfiguration of the position of the gun mountalong the first axis with respect to the lateral member, and detectionof the position of the gun, the gun mount can advantageously beconnected to the lateral member in standard and offset orientationswhich are offset in a dimension which is orthogonal to the first axis.Further, the gun mount is configured to interchangeably support thebiopsy gun in either a vertical orientation or a horizontal orientation,the vertical orientation being rotationally offset from the horizontalorientation by 90 degrees about the first axis or an axis parallel tothe first axis. Moreover, the lateral member can be interchangeablyattached to a first stabilizing feature in right hand and left handorientations which are rotationally offset by 180 degrees. Varioussensors detect these reconfigurations and provide corresponding datathat can be displayed to an operator via the interface module. Further,the interface module can use the data to calculate and displayinformation such as needle aperture position based on knowncharacteristics of the mounted biopsy gun. Still further, the interfacemodule can compare configuration data with a planned configuration toautomatically verify that the configuration is appropriate.

Other features and advantages will become apparent to those of ordinaryskill in the art in view of the figures and detailed description.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 and 2 illustrate a breast biopsy station.

FIG. 3 is an isometric view of a lateral arm needle guide forstereotactic biopsy.

FIG. 4 is an exploded view of the lateral arm needle guide of FIG. 3.

FIG. 5 is a top view of the lateral arm needle guide of FIG. 3.

FIG. 6 is a front view of the lateral arm needle guide of FIG. 3.

FIG. 7 illustrates an X-Axis slide lock for the slide assembly of thelateral arm needle guide.

FIG. 8 is a front view of the X-Axis slide lock of FIG. 7 in the lockedstate.

FIG. 9 is a front view of the X-Axis slide lock of FIG. 7 in theunlocked state.

FIG. 10 illustrates an X-Axis position indication feature for thelateral arm and gun mount.

FIG. 11 is a cross-sectional view of the lateral arm and gun mount ofFIG. 8 taken along A-A.

FIG. 12 is an isometric view of the lateral arm, gun mount and needleguide in a standard position.

FIG. 13 is an isometric view of the lateral arm, gun mount and needleguide in an offset position.

FIG. 14 is a front view of the lateral arm, gun mount and needle guidein the standard position.

FIG. 15 is a front view of the lateral arm, gun mount and needle guidein the offset position.

FIGS. 16, 17 and 18 further illustrate the standard and offset gun mountpositions.

FIG. 19 illustrates the lateral arm configured for a left hand (LH)procedure.

FIG. 20 illustrates the lateral arm configured for a right hand (RH)procedure.

FIG. 21 illustrates a LH/RH configuration sensing feature.

FIG. 22 illustrates a gun mount and orientation sensing feature.

FIG. 23 illustrates a horizontal gun mount configuration with respect toFIG. 22.

FIG. 24 illustrates a vertical gun mount configuration with respect toFIG. 22.

FIG. 25 illustrates a table of potential configurations andcorresponding sensor indications.

DETAILED DESCRIPTION

FIGS. 1 and 2 illustrate a breast biopsy station 1000. The patient ispositioned with her chest wall 1002 against the breast platform 1004 andcompression paddle 1006. The patient's breast is positioned on thebreast platform and placed under compression by a compression paddle,i.e., the breast is between the platform and the compression paddle. Aradiographic imaging system 1008 produces an image of the breast inorder to locate a feature of interest, e.g., a lesion. An integratedguided biopsy needle control device 1010 is used to obtain a tissuesample of the feature of interest. More particularly, the biopsy needlecontrol device displays information about the location of the targetedfeature and the biopsy gun 101 to help position the biopsy gun to wherethe operational path of the needle intersects with the target feature.

FIGS. 3, 4, 5 and 6 illustrate the needle control device 1010 (FIG. 1)in greater detail. The device includes a gun mount 100, lateral arm 102,needle guide 103, biopsy guidance module 105, support arm 107, controlmodule 109, and slide assembly 110. The gun mount 100 is connected tothe slide assembly 110. The slide assembly 110 is connected to thelateral arm 102. The lateral arm 102 is connected to the biopsy guidancemodule 105 via both a post member 106 of the biopsy guidance module andan optional articulating support arm 107. The biopsy control module 109is also connected to the biopsy guidance module 105.

The gun mount 100 is configured to position and secure a selected biopsygun 101. More particularly, an operator can securely mount and removeany of various biopsy guns that might be selected, so different biopsyguns may be utilized as needed. Indexing features help assure that thebiopsy gun can be predictably and repeatedly mounted in a particularposition with respect to the gun mount when mounted. The biopsy gun 101is operative in response information from an embedded computer,information provided by an operator via the biopsy guidance module 105and biopsy control module 109, and sensor input that will be describedbelow to locate a biopsy needle of the biopsy gun to obtain a tissuesample, e.g., by inserting an outer cannula into a predeterminedlocation of interest within the patient, extracting a tissue core sampleby moving an inner cannula relative to the outer cannula, and removingthe needle from the patient. The needle guide 103 helps to guide theouter cannula of the biopsy gun, e.g., by inhibiting deflection. Varioustypes of biopsy guns and needles are known, and the functioning ofbiopsy guns and needles in obtaining tissue cores is well understood inthe art. Therefore, these features will not be described in greaterdetail. As will be described in greater detail below, aspects of thelateral arm needle guide device include interface features whichcalculate, utilize and display useful information, reconfigurationfeatures which allow secure repositioning of the selected biopsy gun,and sensing features which detect certain reconfiguration andrepositioning data in order to facilitate the biopsy procedure, e.g., byproviding the data to the biopsy guidance module and biopsy controlmodule in order to automate calculation of offsets, adjustments andother information that helps to obtain tissue cores from a specificlocation. Moreover, the data can be used to verify that a configurationentered by an operator matches the actual configuration of the device.

Identifying characteristics of the particular gun and needle being usedcan be entered by the operator via the biopsy control module 109, e.g.,model number, individual device identifier, performance characteristics,etc. The biopsy guidance and control modules include at least oneembedded computer with a processor and potentially other processinghardware, and software stored on non-transitory computer readablememory. A database of characteristics of various biopsy guns and needlesmay also be stored in the memory. The known characteristics of thebiopsy gun (including the needle) can be used by the embedded computerto help calculate and display information to assist the operator as willbe explained below.

One aspect of repositioning the biopsy gun 101 is via movement of thelateral arm 102. The lateral arm is repositionable with respect to thebiopsy guidance module 105. In particular, the biopsy guidance module105 includes a clamp member 150 which can be slidably moved along andsecured to the post member 106 at any of various locations along thelength of the post member. Moreover, the clamp member 150 includes athreaded fastening member 152 attached to a knob 154 for securing adistal end of the lateral arm 102 to the clamp member, thereby fixingthe location of the lateral arm 102 relative to the biopsy guidancemodule 105. The position of the biopsy gun and lateral arm with respectto the biopsy guidance module is made even more stable and secure withassistance from the articulating arm support 107, if the support arm ispresent. In the illustrated example the optional articulating armsupport includes two support arms 156, 158 connected at distal ends viaa lockable attachment 160 which can pivot in two-dimensions. Moreover,the other distal end of the first arm 156 is attached to the biopsyguidance module via a lockable attachment 162 which can pivot inthree-dimensions, and the other distal end of the second arm 158 isattached to the lateral arm 102 via a lockable attachment 164 which canpivot in three-dimensions. Consequently, the lateral arm is free to movewith the clamp member 150 relative to the post member 106 when thepivoting attachments 160, 162, 164 are in an unlocked, free-movingstate. When the clamp member 150 is secured to the post member 106 andthe lateral arm 102, additional support is provided by turning the knobsof the pivoting attachments to change their state from the unlockedfree-moving state to a locked non-moving state. This results in thebiopsy gun 101 being repositionable via movement of the lateral arm,with stable multi-point support of the lateral arm at different distalends when the lateral arm is secured in position relative to the biopsyguidance module.

Another aspect of repositioning the biopsy gun 101 is moving the gunrelative to the lateral arm 102. Parallel rails 166 are disposed onopposite sides of the lateral arm (only the near side rail shown). Theslide assembly 110 includes four rotatable wheels 301 which engage andride along the rails (two wheels on each rail) and allow the slideassembly to slidably move along the rails with respect to the lateralarm. Locking features which will be described below in greater detailallow the slide assembly to be secured in a desired position relative tothe rails when in a locked state. More particularly, when the lockingfeatures are in an unlocked state the slide assembly is free to moveslidably along the rails but is otherwise secured to the lateral arm bythe wheels and rails. The gun mount 100 can be secured to the slideassembly via threaded fastening members, and the biopsy gun can besecured to the gun mount. Consequently, when the locking features areunlocked the biopsy gun can be moved slidably along an X-Axis withrespect to the lateral arm, and the biopsy gun can be secured inposition relative to the lateral arm when the locking features arelocked.

FIGS. 7, 8 and 9 illustrate a slide assembly 110 locking featureincluding an X-Axis slide lock. As mentioned above, the slide assembly110 includes four grooved wheels 301 that ride along rails 166 (FIG. 1B)disposed on opposite sides of the lateral arm 102 along the X-axis. Theillustrated X-axis slide lock mechanism utilizes a spring loaded lockingplate 400 (note spring 401) to leverage against a round locking shaft103 to hold the X-Axis position of the slide assembly 110 in any of aninfinite number of positions along its length of travel along the rails.The lock/release interface is a knob 402 at the end of a square camdrive shaft 404. The lock/release is actuated by turning the knob 402through 180 degrees, which fixes the slide assembly in a location thatdoes not traverse the X-Axis because of friction between the round shaft103 and the locking plates 400 which are actuated by the lock/releasecam 406. This advantageously allows the slide assembly to be securelyand easily locked in place, which is helpful because needle position canbe affected during insertion if the position of the biopsy gun isinsecure.

FIGS. 10 and 11 illustrate a sensor feature for detecting the X-Axisposition of the slide assembly 110 relative to the lateral arm 102. Thesensor feature generates data indicative of the position of the slideassembly relative to the lateral arm, and transmits that data to thebiopsy guidance module and biopsy control module. As previouslymentioned, the slide assembly 110 includes grooved wheels 301 that ridealong rails 166 attached to opposite sides of the lateral arm 102. Theslide assembly includes an active position sensing circuit board 104which is proximate to a side of the lateral arm. A corresponding passivereference circuit board 106 is disposed on that side of the lateral arm.In particular, the active position sensing circuit is positionedadjacent to the passive reference circuit board such that the activeposition sensing circuit board 104 can detect position with respect tothe corresponding passive reference circuit board 106. Suitable absoluteposition encoders are known; see, for example, U.S. Pat. No. 4,879,508,issued Nov. 7, 1989. As the active position sensing circuit boardtravels with the slide assembly it generates absolute X-axis positiondata of the gun mount (and thus the biopsy gun) relative to the lateralarm rail. The position data is provided to the embedded computer of thebiopsy guidance module to enable calculation and display of informationbased on the X-axis position data, the known characteristics of themounted biopsy gun and needle combination, or both. For example, needleaperture position may be calculated and displayed on the biopsy controlmodule. This will advantageously help to obviate the need for the doctoror technician to manually calculate the needle aperture position, e.g.,from the position as read from a visible scale mounted on the lateralarm.

FIGS. 12, 13, 14, 15, 16, 17, and 18 illustrate a Y-axis reconfigurationfeature. The gun mount 100 includes a secondary fastening member so thatthe gun mount can be detached from the lateral arm slide assembly 110 ina standard position (shown in FIGS. 12, 14) and re-attached at an offsetposition (shown in FIGS. 13, 15). The needle guide 103 can be detachedand re-attached to the gun mount as needed per procedure configuration.The two mounting positions (standard, offset) are offset along theY-axis. This advantageously allows the biopsy gun needle to bepositioned farther back from the chest wall 1002 of the patient whendesirable. More particularly, this helps accommodate a wider range ofbreast sizes, e.g., utilizing the offset position for larger breasts. Inthe illustrated example each mounting position includes two locationpins 200 on the gun mount which are inserted into corresponding socketsin the lateral arm. The slide assembly includes a captive machine screwand integral knob 202. The machine screw is secured to threadedsocket(s) in the gun mount. Note that FIGS. 16 and 18 also illustrate avertical/horizontal gun mount reconfiguration that will be described ingreater detail below.

FIGS. 19, 20 and 21 illustrate a sensor feature 300 that detects lateralarm mounting configuration. As previously described, the biopsy guidancemodule 105 (FIG. 3) includes a clamp member 150 which can be slidablymoved along and secured to the post member at any of various locationsalong the length of the post member. The clamp member 150 includes guideposts and a threaded fastening member actuated by a knob 154 forpositioning and securing the clamp member relative to the lateral arm102. The lateral arm includes corresponding smooth and threaded socketsfor receiving the guide posts and threaded fastening member. Moreover,different sets of such locating and securing features are provided onopposite sides of the lateral arm, thereby allowing the lateral arm tobe secured to the clamp member (and thus the biopsy guidance module) ineither a left hand (LH) or right hand (RH) orientation. The sensingfeature 300 automatically detects whether the lateral arm 102 isconfigured for a left hand (LH) procedure (as shown in FIG. 19) or aright hand (RH) procedure (as shown in FIG. 20). The sensing featureprovides this data to the embedded computer of the biopsy control andbiopsy guidance modules. The embedded computer can display the data forthe user and use the data to verify that the lateral arm components havebeen installed according to the selected procedure entered by theoperator via the biopsy control module. The illustrated sensing featureutilizes analog Hall Effect sensors 306 with a fixed magnet 308. When adowel pin 310 of magnetizable material (as integrated into a BiopsyGuidance Module Z-Axis Gun Mount) is within a close proximity of thesensor/magnet pair, the magnetic flux level passing through the sensorincreases. The levels at which the pin is and is not detected as beingpresent are recorded by the embedded computer and are used to determinethe RH/LH mounting orientation based on which sensor is closest to adowel pin. This advantageously enables automatic verification ofconfiguration for LH and RH procedures.

FIGS. 16, 18, 22, 23 and 24 illustrate vertical/horizontal gun mountreconfiguration and a gun mount type and orientation sensing feature. Aspreviously described, the gun mount 100 is connected to the slideassembly 110. Proper orientation and secure attachment can beaccomplished with a threaded fastening member, threaded socket, and oneor more guide posts and corresponding smoothbore sockets. Moreover,separate sets of such positioning and securing feature are provided onboth a side and a bottom of the slide assembly to permit both horizontaland vertical mounting. FIG. 23 specifically shows the horizontal gunmount position with respect to FIG. 22. FIG. 24 specifically shows thevertical gun mount position with respect to FIG. 22. The threadedfastening member may be actuated by a knob in order to facilitatereconfiguration between the horizontal and vertical positions. Theillustrated sensing feature utilizes bipolar or unipolar digital HallEffect sensors 320-1, 320-2, 320-3, 320-4 to detect magnets 322 when inclose proximity. Four sensors are used in specific locations todetermine which type of gun mount is attached and in which orientation,e.g., horizontal gun mount orientation or vertical gun mountorientation. Two magnets are permanently installed in each gun mount.

Referring to FIG. 25, the locations of sensors and magnets, e.g., asdepicted in FIGS. 22, 23 and 24, enable detection of each of sixdifferent potential configuration combinations. The sensor data isprovided to the embedded computer of the biopsy control and guidancemodules to enable display of the detected configuration and automaticconfiguration verification for horizontal or vertical gun mounts ineither left hand or right hand configurations for both standard andoffset positions. For verification purposes the operator may be requiredto enter a planned configuration via the biopsy control module beforeperforming the biopsy procedure. The entered planned configuration wouldbe compared with the sensor data by the guidance or control module inorder to verify that the actual device configuration matches the plannedconfiguration. If the actual and planned configurations do not matchthen an alert may be provided to the operator. For example, thenon-matching configuration parameters might be displayed on the biopsycontrol module.

While the invention has been described through the above examples andfeatures, it will be understood by those of ordinary skill in the artthat a wide variety of modifications, combinations and variations of theexamples and features may be made without departing from the inventiveconcepts herein disclosed. Moreover, the invention should not be viewedas being limited to any specific purposes described herein, but rathershould be viewed as being applicable to accomplish a wide variety ofpurposes beyond those described herein.

1. A breast biopsy system comprising: a lateral member, wherein thelateral member has a longitudinal axis; a slide assembly, wherein theslide assembly is slidably mounted on the lateral member, wherein theslide assembly has a longitudinal axis and wherein the longitudinal axisof the slide assembly is generally parallel to the longitudinal axis ofthe lateral member; and a gun mount configured to support a biopsy gun,the gun mount being connected to the lateral member via the slideassembly, wherein the gun mount is movable by sliding the slide assemblyon the lateral member along a first axis with respect to the lateralmember, the first axis being along an insertion direction of the biopsygun into a patient.
 2. The breast biopsy system of claim 1 wherein thegun mount can be interchangeably connected to the lateral member infirst and second orientations which are offset in a dimension which isorthogonal to the first axis.
 3. The breast biopsy system of claim 1wherein the gun mount is configured to interchangeably support thebiopsy gun in either a vertical orientation or a horizontal orientation,the vertical orientation being rotationally offset from the horizontalorientation by 90 degrees about the first axis or an axis parallel tothe first axis.
 4. The breast biopsy system of claim 1 wherein thelateral member is movable along at least a second axis.
 5. The breastbiopsy system of claim 1 further comprising a biopsy guidance module,wherein the lateral member can be interchangeably connected to thebiopsy guidance module in left hand and right hand orientations.
 6. Thebreast biopsy system of claim 1 further comprising a first stabilizingfeature which attaches to the lateral member at a first attachment pointand a second stabilizing feature which attaches to the lateral member ata second attachment point.
 7. The breast biopsy system of claim 6wherein the lateral member can be interchangeably attached to the firststabilizing feature in right hand and left hand orientations which arerotationally offset by 180 degrees.
 8. The breast biopsy system of claim6 wherein the second stabilizing feature includes an articulatingsupport arm.
 9. The breast biopsy system of claim 1 further comprising afirst axis slide lock having a locking plate which leverages against around locking shaft to prevent movement of the gun mount along the firstaxis when in a locked state.
 10. The breast biopsy system of claim 1wherein the slide assembly includes at least one wheel, said at leastone wheel being configured to ride along the lateral member.
 11. Thebreast biopsy system of claim 5 wherein the gun mount is configured tointerchangeably support the biopsy gun in vertical and horizontalorientations and wherein the gun mount can be interchangeably connectedto the lateral member in first and second orientations which are offsetin a dimension which is orthogonal to the first axis.
 12. The breastbiopsy system of claim 11 further comprising a first sensor, a secondsensor, a third sensor, and a fourth sensor, the first sensor detectinga position of the gun mount along the first axis with respect to thelateral member and generating positional data which is provided to aninterface module, the second sensor detecting whether the gun mount isconfigured to support the biopsy gun in the vertical or horizontalorientation and generating corresponding data that is provided to theinterface module, the third sensor detecting whether the lateral memberis in the left hand or right hand orientation and generatingcorresponding data that is provided to the interface module, and thefourth sensor detecting whether the gun mount is connected to thelateral member in the first or second orientation and generatingcorresponding data that is provided to the interface module.
 13. Thebreast biopsy system of claim 12 wherein the interface module uses thepositional data to calculate and display needle aperture position basedon known characteristics of the mounted biopsy gun.
 14. The breastbiopsy system of claim 12 wherein the first sensor includes an activeposition sensor which slides with the gun mount and a passive referencedevice fixed to the lateral member.
 15. The breast biopsy system ofclaim 12 wherein the interface module includes a computer whichdetermines at least one characteristic of the biopsy gun based onoperator input.
 16. The breast biopsy system of claim 11 furthercomprising a first sensor, a second sensor, and a third sensor, thefirst sensor detecting a position of the gun mount along the first axiswith respect to the lateral member and generating positional data whichis provided to an interface module, the second sensor detecting one of(i) whether the gun mount is configured to support the biopsy gun in thevertical or horizontal orientation, (ii) whether the lateral member isin the left hand or right hand orientation, and (iii) whether the gunmount is connected to the lateral member in the first or secondorientation, and generating corresponding data that is provided to theinterface module, and the third sensor detecting a another one,different from the first sensor, of (i) whether the gun mount isconfigured to support the biopsy gun in the vertical or horizontalorientation, (ii) whether the lateral member is in the left hand orright hand orientation, and (iii) whether the gun mount is connected tothe lateral member in the first or second orientation, and generatingcorresponding data that is provided to the interface module.
 17. Thebreast biopsy system of claim 1 further comprising a biopsy guidancemodule comprising a post member, wherein the biopsy guidance modulefurther comprises a clamp member that may be slidably moved along thepost member and secured to the post member at various locations alongthe post member and wherein the lateral member is secured to the clampmember, whereby the lateral member may be adjustably positioned atvarious locations along the post member.
 18. The breast biopsy system ofclaim 1 wherein the lateral member comprises a pair of rails and whereinthe slide assembly comprises at least a first wheel that engages andrides along one of the pair of rails and at least a second wheel thatengages and rides along the other of the pair of rails.
 19. The breastbiopsy system of claim 18 further comprising a slide assembly lock, theslide assembly lock comprising a spring loaded locking plate whichleverages against a round locking shaft on the lateral member to preventmovement of the slide assembly along the first axis when in a lockedstate.
 20. The breast biopsy system of claim 19 wherein the slideassembly lock further comprises a lock release to selectively disengagethe spring loaded locking plate from the round locking shaft.